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Идёт набор NCT05766475

In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression

Без фазы С лечением Postpartum Depression

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ROSE Program: In Person, ROSE Program: Virtual.
Кому может быть актуально
Состояния в реестре: Postpartum Depression. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Group-based Prevention of Postpartum Depression: In-person vs. Virtual Delivery

Обзор

The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.

Подробное описание

Depression is one of the most common perinatal complications, with 1 in 7 mothers qualifying for a diagnosis of postpartum depression (PPD) and even higher rates for those who identify as Hispanic/Latine, Black or African American, American Indian, or Alaska Native, or by multiple races or ethnicities. This project addresses this major gap in services to prevent PPD, particularly among socioeconomically disadvantaged and minoritized groups. It tests the benefit of a virtual perinatal preventive intervention in English and Spanish to increase access, scalability and address the mental health needs of underserved populations. This project will test the virtual version against the in-person version of a service-ready efficacious preventive intervention in a randomized controlled trial (RCT). This trial will provide a test of a preventive intervention with a strong evidence base that is scalable and can be delivered with fidelity by service providers in settings where obstetric care is received. In this project, pregnant women will be randomized to receive an evidence-based group prevention program (Reach Out, Stay Strong, Essentials for New Moms; ROSE) designed for perinatal populations either a) in person, delivered at the hospital where they are receiving prenatal care or b) virtually, delivered by the same staff via video conferencing, both offered in English and Spanish. Diverse pregnant individuals (N = 900) will be randomized to receive virtual or in-person ROSE. The central outcome, depression, will be assessed via REDCap surveys, prenatally (before the program begins and at the end of gestation) and postpartum (approximately six-weeks, 3, 6, and 12-months after birth). Electronic health records (EHRs) and surveys will be used to examine obstetric, mental health (e.g., standard of care depression screening), and sociodemographic factors linked to health disparities that may impact who benefits most.

Вмешательства

  • Поведенческое ROSE Program: In Person
    In-person preventative intervention for postpartum depression that includes content on building social support and communication skills in relationships, navigating the role transition to motherhood, and learning about signs and symptoms of depression after delivery.
  • Поведенческое ROSE Program: Virtual
    Virtual ROSE covers the same content (e.g. improving social support and communication) and is delivered by the same facilitators as the in-person intervention via telehealth.

Первичные конечные точки

  • Symptom Checklist 20 (SCL 20) [Срок оценки: 6 weeks after birth]
  • Symptom Checklist 20 (SCL 20) [Срок оценки: 3 months after birth]
  • Symptom Checklist 20 (SCL 20) [Срок оценки: 6 months after birth]
  • Symptom Checklist 20 (SCL 20) [Срок оценки: 12 months after birth]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [Срок оценки: 6 weeks after birth]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [Срок оценки: 3 months after birth]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [Срок оценки: 6 months after birth]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [Срок оценки: 12 months after birth]

Критерии участия

Критерии включения

  • English or Spanish speaking
  • Less than 30 gestational weeks

Критерии исключения

  • None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Denver Health Medical Center — Denver

Публикации

  • Liu DY, Perry NS, Demers CH, Hyer JS, Alamo A, Vuksanovich P, Dube N, Flanagan ER, Gallop RJ, Rhoades GK, Davis EP. Virtual versus in-person ROSE program (La Luz) as universal prevention for perinatal depression: Protocol for a randomized controlled trial in a safety net hospital. Contemp Clin Trials. 2025 Aug;155:107988. doi: 10.1016/j.cct.2025.107988. Epub 2025 Jun 15. PMID 40527396

Идентификаторы

NCT: NCT05766475 · 1916994-3 · R01MH130976-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗